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Axillary Brachial Plexus BlockNCT05466500

The Efficacy of Intravenous Dexamethasone on the Duration of Analgesia of Ultrasound Guided Axillary Brachial Plexus Block in Pediatric Patients Undergoing Below Elbow Orthopaedic Surgeries

A study testing Ultrasound guided axillary block with intravenous dexamethasone and Ultrasound guided axillary block in people with Axillary Brachial Plexus Block, run by Kasr El Aini Hospital at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Postoperative pain is a common manifestation in orthopedic patients, mainly due to intraoperative tissue damage , inadequate intraoperative pain assessment and management. Axillary nerve block provides motor and sensory block with the distribution of the median, radial, ulnar and musculocutaneous branches so it can be… Read more about this study

Who is it for?
Ages 4 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Axillary Brachial Plexus Block
What is being tested?
Ultrasound guided axillary block with intravenous dexamethasone and Ultrasound guided axillary block
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
26 Jul 2022to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Gender both males and females
  • ASA ClassI-II
  • Age 4-14 years
  • Patients under going upper limb orthopaedic surgery in the hand, wrist, and elbow distal to the cubital fossa

Who cannot join

  • Parent refusal.
  • Patients with apparent infection at site of needle insertion.
  • Patients with any coagulation disorder(Platelets ≤ 50,000 and/or INR> 1.5)
  • Patients with known neuropathy or brachial plexus injury.
  • Patient with known sensitivity to local anesthetic drugs

Trial locations and contacts

1 site in 1 country.

Ahmed nabih, lecturer contact

01002773488 ext. 202

nabihomar100@yahoo.com

Abdelmoneim adel, lecturer contact

01004392046

Abdelmonemadel87@gmail.com

Egypt1 site, 1 recruiting
  • Kasr Alainy, Cairo University

    Cairo

    Ahmed nabih, lecturer, 01002773488 ext. 202, nabihomar100@yahoo.com

    Abdelmoneim adel, lecturer, 01004392046 ext. 202, Abdelmonemadel87@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: The Efficacy of Intravenous Dexamethasone on the Duration of Analgesia of Ultrasound Guided Axillary Brachial Plexus Block in Pediatric Patients Undergoing Below Elbow Orthopaedic Surgeries: A Randomized Control Trial

Postoperative pain is a common manifestation in orthopedic patients, mainly due to intraoperative tissue damage , inadequate intraoperative pain assessment and management.

Axillary nerve block provides motor and sensory block with the distribution of the median, radial, ulnar and musculocutaneous branches so it can be conducted with upper limb orthopedic surgery in hand, rest and elbow surgery distal to the cubital fossa.Sensory blockade of the brachial plexus for perioperative analgesia leads to stable haemodynamics intraoperatively, smoother emergence from general anaesthesia and decreased need for supplemental analgesics or suppositories in the Post-operative period Intravenous (IV) dexamethasone has been used as an additive to local anesthetic for peripheral nerve blocks (PNBs) in adults with variable efficacy.To the best of our knowledge the efficacy of intravenous dexamethasone as adjuvant to bupivacaine in ultrasound guided axillary brachial plexus block in pediatrics has not been investigated

Read more

In this study the investigators will assess the analgesic effect of adding intravenous dexamethasone to bupivacaine in ultrasound guided axillary block in children undergoing upper limb orthopedic surgeries.

Objectives:

  • To determine the effect of adding intravenous dexamethasone on the duration of analgesia .
  • To determine the effect of adding intravenousdexamethasone on quality of analgesia
Read the detailed description

This a randomized control trial is designed to include (60) patients ASA physical statusI-II patients ranging from(4) to(14)years old scheduled for upper limb orthopaedic surgery in the hand, wrist, and elbow distal to the cubital fossa.

Patients meeting the inclusion criteria will be randomly assigned to receive either :

Group A :Axillary block with 2 mg/kg of 0.25% bupivacaine. (n=30) Group B: Axillary block with 2 mg/kg of 0.25% bupivacaine plus 0.1mg/kg dexamethasone intravenous:(n=30)

All children will be anaesthetized in accordance with the local policy of the Abu El-Reesh pediatric hospital-Cairo university's pediatric anaesthetic unit. Except for oral clear liquids intake 2 hours before surgery, all children will fast for 6 hours. Patients will attend in the preparation room one hour before the operation to get a preoperative checkup, as well as their age and body weight will be recorded. Pre medicated by intramuscular injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg before insertion of intravenous (I.V) cannula.On arriving the operating room, heart rate (HR) ,oxygen saturation and non-invasive blood pressure will be continuously recorded, using standard monitor (Dräger infinity vista XL).

All patients will be induced with propofol 2 mg / kg , atracurium 0.5mg/kg and fentanyl 1μg/kg, then the patients will be intubated by appropriate size of endotracheal tube volume control ventilation (VCV) 5-7 ml/kg and respiratory rate will be adjusted to keep and PaCO2 levels between 30-35 mmHg using (G.E-Datex-Ohmeda, Avance CS2, USA) anesthesia machine. Anesthesia will be maintained with isoflurane 1 MAC with 50% oxygen in air, with the goal of keeping the BIS measurement between (40-60), and atracurium top-ups of 0.1mg/kg will be given every 30 minutes for neuromuscular blockade.Then the block will be conducted after general anesthesia by an expert anesthesiologist who is different from the anesthesiologist who provided anesthesia to the patient.

Axillary block

Axillary nerve block will be induced with patient in supine under GA with ultrasound SonoSite M Turbo (USA), the scanning probe will be the linear multi-frequency 6-13 MHz transducer (L25 x 6-13 MHz linear array).The probe will be protected with sterile cover, antiseptic betadine will be applied to the site of block injection , the operating arm will be abducted by 70 externally rotated, and the elbow will be flexed to ~90. Within the axillary crease the probe position will be placed sagittal where bounded by the pectoralis major antero-medially and the latissimus dorsi and teres major posteromedial.

The probe will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles .The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked. The block will be applied by 50-mm block needle 22 gauge at cephalic side of the probe. The same volume of local anesthetic will be used in each group with 2 mg/kg of 0.25% bupivacaine. Group A will receive 2ml of saline solution i.v after completing the block,Group B will receive 0.1mg/kg dexamethasone i.v after completing the block.

The time passed between the entrance of the needle into the skin and the injection's completion is referred to as axillary block performance time.The end of the local anesthetic solution injection will be considered the time zero to assess the blockade effectiveness. The surgical procedure will be start after 15-20 min.

If there is an increase in heart rate or mean arterial blood pressure of more than 20% of the baseline value after skin incision then it will be considered asblock failure and these patients will be excluded from the study. 1-2ug/kg intravenous fentanyl will be given to failed block. At the end of surgery,residual neuromuscular block will be antagonized with IV neostigmine 0.05 mg/kg and atropine 0.02mg/kg. All patients will receive 15mg/kg paracetamol IV every 6 hours.

Postoperative

  1. The postoperative pain assessment in the PACU and the wardwill be performed using a (FLACC score)(APPENDIX 1)(10).Patients will be assessed immediately postoperatively and then at 1st, 4th, 8th, 12th , 24 hour post-operatively.Patients with pain score more than 3\10 ,Pethidine I.V will be given as rescue analgesic (1 mg/kg) when needed.The time to first request of postoperative analgesic is defined as( the time interval from LA injection to first dose of pethidine adminstration) will be recorded. The total amount of pethidine in the first postoperative 24 hours will be calculated in both groups.
  2. Block related complications will be recorded such as failed block, local anaesthetic toxicity, vascular puncture, paresthesia.

Measurement tools

  1. Patients demographic data will be collected; age, gender, height,weight , type and duration of surgery
  2. Block time duration, Surgical procedure , duration and Axillary block performance time.
  3. Intraoperative haemodynamic (Heart rate ,systolic and diastolic blood pressure)pre-induction , post-intubation , post-block , immediate post skin incision , every 15 minutes.
  4. Postoperative pain assessments using(FLACC score)at at 0 point 1hr, 4hr, 8hr ,12 hr, and at 24 hr
  5. Time to first request of rescue postoperative analgesic
  6. Total opioid consumption in 24h postoperative
  7. Tourniquet whether used or not and if used time and pressure will be recorded
Being tested
Ultrasound guided axillary block with intravenous dexamethasone, Ultrasound guided axillary block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided axillary block with intravenous dexamethasoneProcedure or surgery

    Also called peripheral nerve block with dexamethasone, bupivacaine and dexamethasone intravenous

    it will be given by one researcher using 2 mg/kg of 0.25% bupivacaine plus 0.1mg/kg dexamethasone intravenous

  • Ultrasound guided axillary blockProcedure or surgery

    Also called peripheral nerve block, bupivacaine only

    it will be given by one researcher using 2 mg/kg of 0.25% bupivacaine

Study groups in NCT05466500
Study groupRoleWhat they receive
Ultrasound guided axillary block with intravenous dexamethasoneActive comparatorThe probe will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identify the hyperechoic median, ulnar, and radial nerves in relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles .The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked and use of intravenous dexamethasone as an adjuvant to bupivacaine for Post-operative analgesia following sensory blockade of the axillary brachial plexus in paediatrics undergoing below elbow orthopaedic surgeries.
Receives: Procedure: Ultrasound guided axillary block with intravenous dexamethasone
Ultrasound guided axillary blockPlacebo comparatorThe probe will be placed parallel to the anterior axillary fold at the axilla to identify the axillary artery and to identifythe hyperechoic median, ulnar, and radial nervesin relation to the axillary artery. The musculocutaneous nerve which supplies the skin of the lateral side of the forearm had to be blocked also. It is found between the biceps brachii and coracobrachialis muscles .The needle is inserted in-plane from the anterior aspect and directed toward the posterior aspect of the axillary artery. All four nerves in the axillary region will be blocked
Receives: Procedure: Ultrasound guided axillary block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first request of opioid analgesia

    Time to first request of opioid analgesia will be"the time interval between LA injection and the first request to postoperative analgesia (first dose of pethidine adminstration)" (minutes)

    Measured: it will be measured in the first 24 hours postoperative

Secondary outcomes (1)
  1. Total opioid consumption 24 hours postoperative

    Total opioid consumption will be consumed in the first 24 hours postoperative

    Measured: It will be measured in the first 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2022
  2. Study start26 Jul 2022
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05466500
Sponsor's protocol ID
N-53-2022
Status last verified
Jul 2022
First submitted
17 Jul 2022
Last updated
27 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound guided axillary block with intravenous dexamethasone and Ultrasound guided axillary block in people with Axillary Brachial Plexus Block, run by Kasr El Aini Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahmed nabih, lecturer (01002773488 ext. 202, nabihomar100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first request of opioid analgesia (time frame: it will be measured in the first 24 hours postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.

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